Cell Therapy Process Engineer

7 days ago


San Diego, California, United States Capricor Inc Full time
Job Summary

Capricor Inc is seeking a highly motivated and detail-oriented Manufacturing Operations Specialist to join our team. As a key member of our Manufacturing group, you will be responsible for supporting the production of biopharmaceutical products for pre-clinical, clinical, and commercial use.

Key Responsibilities
  • Process Development and Optimization: Assist in the development and optimization of manufacturing processes to ensure high-quality products.
  • Technical Transfers: Support the transfer of processes into cGMP manufacturing, ensuring compliance with regulatory guidelines.
  • Manufacturing Operations: Troubleshoot production activities to ensure safe, quality, and timely manufacture of biopharmaceutical products.
  • Documentation and Quality Control: Create and revise process-related manufacturing documentation, including batch records, SOPs, and risk assessments, to ensure compliance with quality, safety, and efficacy standards.
  • Deviation Investigations: Perform investigations to determine root cause and product impact of manufacturing deviations.
  • Process Improvement: Identify opportunities for process improvement and implement corrective actions to increase yield, maximize capacity, and improve operational efficiency.
  • Regulatory Compliance: Ensure compliance with cGMP, ICH, and FDA regulations.
  • Team Collaboration: Work closely with the Quality department and other teams to ensure seamless communication and collaboration.
Requirements
  • Education and Experience: Bachelor's degree and 2+ years of hands-on cGMP biologics manufacturing experience in the pharmaceutical/biotech industry, or equivalent combination of degree/experience.
  • Cell Culture Experience: A minimum of 1 year experience in adherent cell culture, with additional experience in cells in suspension a plus.
  • Technical Writing: Experience with writing and revising technical documents, including SOPs, forms, and batch records.
  • Quality Events: Previous experience with, or knowledge of, various quality events, including deviations, CAPAs, and change controls.
  • Communication and Interpersonal Skills: Exceptional communication and interpersonal skills, with the ability to collect and analyze data to determine paths for process improvement.
  • Technical Proficiency: Demonstrated technical proficiency, scientific creativity, problem-solving skills, and strong GMP principles.
  • Regulatory Knowledge: Full working knowledge of cGMP regulations.
  • Collaboration and Adaptability: Ability to work in a dynamic environment, multi-task, and meet aggressive deadlines, with a demonstrated ability to work independently and as part of a team.


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